Any adverse product experience that is not "serious" and "unexpected" must be reported to the FDA in a periodic report. 21 C.F.R. §§ 314.80(c)(2)(i), 314.98, 600.80(c)(2)(i). Periodic reports must contain a ''narrative summary and analysis" of the information in the report, including an analysis of all 15-day Alert reports filed during that period. 21 C.F.R. §§ 314.80(c)(2)(ii), 314.98, 600.80(c)(2)(ii). Periodic reports must also contain a completed FDA Form 3500A for each adverse product experience not reported in a 15-day Alert report during the period as well as an index consisting of a line listing of the patient identification number and adverse reactions terms. Id. Finally, periodic reports must contain a history of actions taken in response to adverse product experiences during the period, such as labeling changes or initiation of studies. Id.
Follow-up investigations for adverse product experiences that are not "serious" and "unexpected" are not required. If the applicant or licensed manufacturer chooses to perform an investigation, then it may submit any information that it discovers in the next periodic report, rather than filing a separate "follow-up" report. 21 C.F.R. §§ 314.80(c)(2)(i), 314.98, 600.80(c)(2)(i).
During the first 3 years after the date of approval or licensing of a product, periodic reports must be submitted quarterly. 21 C.F.R. §§ 314.80(c)(2)(i), 314.98, 600.80(c)(2)(i). For the purposes of quarterly reports, the first quarter begins on the date of approval of the application. Id. Each quarterly report must be filed within 30 days of the close of the quarter. Id. After 3 years, applicants or licensed manufacturers need only submit annual reports, which must be filed within 60 days of the anniversary of approval or licensing. Id. The FDA may require quarterly reports for a period longer than three years. Id.
Periodic reports need not contain adverse product experience information obtained from reports in scientific literature, foreign marketing experience, or post-marketing studies, including studies conducted under IND applications. 21 C.F.R. §§ 314.80(c)(2)(iii), 314.98, 600.80(c)(2)(iii). Thus, the only adverse product experiences that must be included in periodic reports are those that have not been included in a 15-day Alert report that were reported as spontaneous reports from domestic sources.
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